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OpenTrials
Completed

NCT Number: NCT03651817

Lung Protection Strategy in Open Heart Surgery: Which Tidal Volume is Better 8ml/kg or 6ml/kg

Respiratory complications range from 8% to 79% of the frequency after open heart surgery where the patient is on-pump operated by cardiopulmonary machine. There were many changes in physiology due to anesthesia and cardiac surgery which cause volume and barotrauma complications with mechanical ventilation. These complications increase cost by prolonging morbidity and morbidity as well as hospital stay. Intraoperative and postoperative mechanical ventilation strategies can prevent these complications. CPB stimulates the systemic inflammatory response to the secretion of neutrophil, endotoxin and proinflammatory cytokines in the complex, increasing the permeability of the capillaries. Although coronary artery bypass graft surgery (CABG) is associated with a 0.4% to 2.0% acute respiratory distress syndrome (ARDS), mortality is quite high. Lung-protective ventilation strategies commonly used for prevention of ARDS. Ferrando et al. have proposed pulmonary ventilation with a tidal volume (TV) of less than 10 mL / kg as a pulmonary intraoperative protective ventilation strategy. Investigators aimed to compare oxygenation and ventilation parameters with respiratory mechanics in patients who underwent open heart surgery and were ventilated with 6 ml / kg tidal volume and 8 ml / kg TV, which were recommended as lung protective ventilation strategies during anesthesia.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University Hospital

Kocaeli, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing Cardiopulmonary bypass

Exclusion criteria

  • Severe COPD
  • Chronic Anemia
  • Active Smoker
  • Chronic kidney Disease

Treatment and study plan

Mechanical ventilation

Device

Patients will be ventilated with anesthesia machine according to the group they belong to

Primary outcomes

  1. Change of arterial carbondiokside pressure levels

    Time frame: from the beginning of operation to 6th hour of post-extubation

    Investigators will compare the changes in arterial carbondiokside levels in arterial blood gas samples

Secondary outcomes

  1. Changes in respiratory parameters

    Time frame: from the beginning of the operation to the end of the surgery

    airway pressures will be continuously assessed

  2. Changes in Invasive blood pressures

    Time frame: from the beginning of the operation to the end of the surgery

    Blood pressure will be continuously recorded and assessed due to time intervals

  3. Changes in heart rate

    Time frame: from the beginning of the operation to the end of the surgery

    Heart rate will be continuously recorded and assessed due to time intervals

  4. Changes in central venous pressure

    Time frame: from the beginning of the operation to the end of the surgery

    Continous central venous pressure will ve recorded and assessed due to time intervals

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 29, 2018
Registry last updated
Mar 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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